Press Release

Marengo to Share Updated Clinical Data of Invikafusp Monotherapy Activity in PD1 resistant tumors in a Clinical Plenary Oral Presentation at AACR 2025

  • Data to be presented from the STARt-001 trial demonstrating single agent anti-tumor activity

CAMBRIDGE, Mass., March 25, 2025 /PRNewswire/ — Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy in oncology and autoimmune diseases, will present updated clinical and translational results for its lead selective T cell activator, invikafusp alfa (STAR0602), in a clinical plenary oral presentation at the American Association of Cancer Research (AACR) Annual Meeting taking place April 26-30, 2025, in Chicago, Illinois.

Presentation details:

  • Title: Updated clinical results, recommended phase 2 dose (RP2D) determination and translational study results for START-001: A phase 1/2 trial of invikafusp alfa, a first-in-class TCR β chain-targeted bispecific antibody in patients with anti-PD(L)1-resistant, antigen-rich solid tumors
  • Conference: AACR Annual Meeting 2025
  • Abstract Number: CT205
  • Session Title: Clinical Trials Plenary: Biologics and T-cell Engagers
  • Session Date and Time: Tuesday, April 29, 2025, 10:15 AM – 12:15 PM
  • Presenter: Ryan J. Sullivan, M.D., (Massachusetts General Hospital, Boston, MA, USA)

About Marengo Therapeutics
Marengo Therapeutics, Inc., a clinical-stage biotech company, develops novel TCR-targeting antibodies that selectively modulate common and disease-specific T cell subsets of the germline TCR repertoire to provide lifelong protection against cancer and autoimmune diseases. With a passionate team of dedicated scientists experienced in immunology and oncology, and three proprietary platforms: Selective T Cell Activation Repertoire (STAR), Trispecific T Cell Engager (Tri-STAR) and T cell Depletor (MSTAR), Marengo is working to selectively target the right T cells in the right patients to create a world in which everyone’s immune system can defeat cancer and autoimmune diseases. To learn more, visit marengotx.com.

About the STAR™ Platform
Marengo’s STAR™ Platform is a multi-specific antibody-fusion platform derived from Marengo’s proprietary library of antibodies targeting germline-encoded variable Vβ regions of the TCR fused to different T cell co-stimulatory moieties. Combining a novel non-clonal mode of TCR activation with a T cell co-stimulator in the same molecule promotes a distinct mechanism of action that promotes durable anti-tumor Vβ T cell responses.

About Invikafusp alfa (STAR0602)
Invikafusp alfa (STAR0602) is the lead candidate from Marengo’s STAR™ platform. It is designed to selectively activate a common Vβ T cell subset found in all cancers by combining a non-clonal mode of TCR activation with a T cell co-stimulatory signal in a single molecule. This innovative approach promotes the expansion of clonally diverse, effector memory Vβ T cells, enhancing anti-tumor immunity and enabling durable tumor clearance. Extensive preclinical studies demonstrate STAR0602’s potent anti-tumor activity in both mouse and human ex vivo models via a novel mechanism of action.  

About the STARt-001 Clinical Study
STARt-001 is a Phase 1/2 clinical trial evaluating the safety, tolerability, and preliminary efficacy of invikafusp alfa as a monotherapy in biomarker-selected patients with advanced antigen-rich solid tumors, including PD-1 refractory and rare tumor types. The trial consists of two parts: Phase 1 dose escalation and Phase 2 dose expansion. For more information, visit clinicaltrials.gov (Identifier: NCT05592626).

Patients interested in participating in this study at the National Cancer Institute (NCI) can contact NCI’s toll-free number: 1-800-4-CANCER (1-800-422-6237) (TTY: 1-800-332-8615), visit the website at https://trials.cancer.gov, or email [email protected].

Marengo Contacts:

Media
Peg Rusconi I [email protected] 

Investors
Svetlana Makhni | [email protected] 

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SOURCE Marengo Therapeutics

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